Inspections, Compliance, Enforcement, and Criminal Investigations
Northwest Tofu, Inc.
Department of Health and Human Services
|Public Health Service
Food and Drug Administration
July 1, 2009
VIA FEDERAL EXPRESS
DELIVERY SIGNATURE REQUESTED
In reply refer to Warning Letter SEA 09-20
Yong Huang and Sha Li, Owners
Northwest Tofu, Inc.
1911 South Jackson Street
Seattle, Washington 98144-2224
Dear Mr. Huang and Ms. Li:
The Food and Drug Administration (FDA) conducted an inspection of your food
processing facility, located at 1911 South Jackson Street, Seattle, Washington, on April
21 and 27,2009. The inspection revealed insanitary conditions and violations of the
Current Good Manufacturing Practice (CGMP) regulation for foods, Title 21, Code of
Federal Regulations (21 CFR) Part 110. These conditions cause the food products
produced in your facility to be adulterated within the meaning of Section 402(a)(4) of the
Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 342(a)(4)] in that they
were prepared, packed, or held under insanitary conditions whereby they may have
become contaminated with filth or rendered injurious to health. You may find the Act
and the CGMP regulation through links in FDA's home page at www.fda.gov.
At the conclusion of the inspection, you were issued a Form FDA-483, Inspectional
Observations, which delineated a number of insanitary conditions and CGMP deviations
present in your facility at the time of the inspection. The insanitary conditions and
CGMP deviations are as follows:
1. You must take reasonable measures to maintain cleanliness by ensuring that all
persons working in direct contact with food, food-contact surfaces, and food packaging
materials conform to hygienic practices while on duty to the extent
necessary to protect against contamination of food, to comply with 21 CFR
110.10(b). The methods for maintaining cleanliness include:
• Washing hands thoroughly (and sanitizing if necessary to protect against
contamination with undesirable microorganisms) in an adequate handwashing
facility before starting work, after each absence from the
workstation, and at any other time when the hands may have become soiled
or contaminated, to comply with 21 CFR 110.10(b)(3). However, an
employee was observed to pick up a container from the floor with gloved
hands, by handling the top of the container with one hand while the other
touched the bottom of the container, and then rinse his gloved hands by
submerging them in used wash water in the deep stainless steel sink used
for washing soiled cheese cloths. This same employee was then observed
to handle and cut fresh tofu without changing the gloves.
• Removing all unsecured jewelry that might fall into food, equipment, or
containers, and removing hand jewelry that cannot be adequately sanitized
(or covering hand jewelry that cannot be removed with a material that
effectively protects against contamination) during periods in which food is
manipulated by hand, to comply with 21 CFR 110.10(b)(4). However, your
employees failed to remove all unsecured jewelry that might fall into food
and hand jewelry that cannot be adequately sanitized, as evidenced by
observation of an employee who was cutting the raw tofu for deep frying and
was wearing a chain bracelet that was touching the tofu while the product
was being cut.
2. Effective measures must be taken to exclude pests, including rodents, from the
processing areas and to protect against the contamination of food on the
premises by pests, to comply with 21 CFR 110.35(c). However,you failed to
exclude rodents from your ingredient scaling and mixing room and failed to
protect against the potential contamination of food on the premises by rodents,
as evidenced by observation of apparent rodent excreta droppings (REPS) in
the room as follows:
• 24 apparent REPS on the floor in the northeast corner of the room behind
the desk where a microwave and a food processor portable machine are
• 9 apparent REPS on the floor along the east wall behind the north end of the
food storage rack, within approximately 12 inches of stored bags of food
• 10 apparent REPS on the floor at the west wall/floor juncture within four
inches of stored sacks of sugar.
3. Plants and facilities must be constructed in such a manner as to prevent drip
and condensate from contaminating food and food-contact surfaces, to comply
with 21 CFR 11 0.20(b)(4). However, your facility is not constructed in such a
manner as to prevent drip and condensate from contaminating food and food contact
surfaces, as evidenced by the following:
• Condensation was observed on approximately 50% of the ceiling above the
tofu processing area due to steam released from the soybean cooker and
from the cooked soybean slurry when emptied into the separator. Exposed
soybean slurry and soaking soybeans were being held awaiting processing,
exposed vats of soymilk were being processed, and tofu was being molded
beneath the condensate-covered ceiling area. Condensation was turning into droplets on the ceiling and black specks, which appeared to be mold growth, appeared on several areas of the ceiling where the condensate had formed.
4. Your plant and facility must provide adequate ventilation or control equipment to
minimize odors and vapors (including steam) in areas where they may
contaminate food, to comply with 21 CFR 110.20(b)(6). However, you failed to
provide adequate ventilation or control equipment to minimize vapors (including
steam) in your processing area as evidenced by the significant condensation, as
outlined in item 3 above, forming on the ceiling as a result of steam from the
soybean cooker and lack of an effective ventilation system to expel or exhaust
the steam and moisture.
5. You must ensure that equipment, containers, and utensils used to convey, hold,
or store raw materials, work-in-process, rework, or food are constructed,
handled, and maintained during manufacturing or storage in a manner that
protects against contamination, to comply with 21 CFR 110.80(b)(7). However,
you failed to handle and maintain containers and equipment that hold or convey
food in a manner that protects against contamination, as evidenced by:
• Frayed and splintering wooden molds, used for fresh tofu and fried tofu
production; wooden vats, used for congealing the soybean mash; and
wooden presses, used for the production of spiced tofu. All of these wooden
utensils showed signs of wear, splintering, fraying, and signs of saturation.
During the inspection your firm stated that you had received complaints from
consumers who found pieces of wood fiber in the product.
• Chipped paint and rust on the sides of the spout of the soybean mill and its
surrounding area where ground soybeans exit from the mill.
• Unpackaged cut tofu on a stainless steel sheet pan was placed on a corner
of the cutting table against a painted metal support beam that exhibited
chipped paint and dirt in areas next to the sheet pan.
• A cracked and broken-edged plastic food tray was used in inverting the tofu
from the mold and for cutting into portions.
• Oil droplets have accumulated on the frame cooling rack which holds open
trays of fresh tofu for cooling and deep frying, in the northwest corner of the
processing room by the deep fat fryer wok.
6. You must maintain the buildings, fixtures, and other physical facilities of your
food plant in a sanitary condition and in sufficient repair to prevent food from
becoming adulterated within the meaning of the Act, to comply with 21 CFR
110.35(a). However, the buildings, fixtures, and other physical facilities of your
food plant were not kept in a sanitary condition as evidenced by:
• Apparent mold growth on the ceiling above the soymilk production, tofu
molding, tofu spicing, and tofu cooling deep sink areas, including apparent
mold growth on the plywood directly above the 3-compartment sink where a
stack of clean sheet trays, a clean cutting board, and green onions in a
stainless steel bowl (having been prepped for incorporation in the onion
pancakes in production) were stored.
• Observation of grime and old food matter on the southwest wall and on the
hand contact area of the light switch by the south door of the processing
room approximately one foot away from the fried ready-to-eat Chinese
doughnuts, which were cooling on a work table. Also, the hand contact area
of the floor broom handle was observed covered with food residue and was
propped on the backsplash three inches away from the doughnuts.
• Observation of food residues accumulated on the plastic strip curtain at the
entrance of the walk-in cooler, through which uncovered/exposed food
• Observation of dust and food residue accumulation on the storage rack
where various utensils were stored toward the middle of the processing
7. You must conduct all food manufacturing, including packaging and storage,
under such conditions and controls as are necessary to minimize the potential
for the growth of microorganisms or for the contamination of food, to comply with
21 CFR 11 0.80(b)(2). However, you failed to conduct food manufacturing under
such conditions and controls as are necessary to minimize the potential for the
growth of microorganisms or the contamination of food as evidenced by the
• Empty used 50-lb paper soybean shipping bags, which were soiled with food
residue, were used as liners for the food cart that held the fried cut and fresh
tofu, and were used to cover the cleaned steam-jacketed kettle/masher at
the end of the production day.
8. You must provide your plant or facility, where necessary, adequate screening or
other protection against pests, to comply with 21 CFR 110.20(b)(7). However,
you did not provide adequate screening or other protection against pests as
evidenced by observation of a gap measuring approximately three inches in
length at the back alley customer entrance door and a hole measuring
approximately five inches in diameter in the ingredient mixing/storage room.
We have received your response to the Form FDA-483, Inspectional Observations
(483), in which you state you have corrected or you promise to correct the deficiencies
listed. We appreciate your written response and any corrective efforts you have made
regarding the violations; however, the response does not adequately address the
violative conditions that existed at the time of inspection. With the exception of repairing
the floor, your written response promises future correction of the observations noted on
the 483, but does not specify when or exactly how these corrections will be completed.
A review of our files also finds that you have sent written responses indicating correction
of or making promises to correct the same or similar sanitation problems noted during
inspections conducted by the Washington State Department of Agriculture, Food Safety
Program, in November 2007, February 2006, and June 2004; however, sanitation
deficiencies continue at your facility despite your past promises to take corrective
The above violations are not meant to be an all-inclusive list of deficiencies in your
facility. It is your responsibility to assure that all of your products are in compliance with
applicable statutes enforced by the FDA. You should take prompt action to correct all of
the violations noted in this letter. Failure to promptly correct these violations may result
in regulatory action without further notice, such as seizure and/or injunction.
Please respond in writing within fifteen working days from your receipt of this letter.
Your response should outline the specific things you are doing to correct these
deviations. If you cannot complete all corrections before you respond, we expect that
you will explain the reason for your delay and state when you will correct any remaining
Please send your reply to the Food and Drug Administration, Attention: Michael J.
Donovan, Compliance Officer, 22201 23rd Drive SE, Bothell, Washington 98021-4421.
If you have questions regarding any issue in this letter, please contact Michael J.
Donovan, Compliance Officer, at (425) 483-4906.
Charles M. Breen
Form FDA 483
cc: WSDA with disclosure statement